Sr. Manager - Reg. Affairs
- Genpact India
- 2 to 7 Yrs
- Mumbai
- 4 years ago
- Email to a friend
- Report this job
Job Description
*With a start-up spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it. Come, transform with us.
Are you the leader we are looking for
Inviting applications for the role of SM, Labeling Management System Lead
Responsibilities
Establish and maintain culture in R&D that supports compliance with labelling process management and innovation to drive continuous improvement of the system and processes
Develop and deliver training on labelling systems, and become a single point of contact for queries raised by end users related to labelling systems across HA and Country RA
Lead large-scale change initiatives across R&D, Manufacturing, and Marketing related to the labeling process
Develop labeling process capabilities including regulatory-, system-, and business process knowledge
Ensure alignment cross-functionally outside of R&D and throughout the enterprise to develop and improve enterprise-wide process optimization
Manage Change Control of the labeling processes and associated systems
Manage Business Requirements and partner with IT to develop systems requirements
Oversee user acceptance testing preparation and execution for new system/upgrade evaluation; communicate and lead Change Management of system initiatives
Drive process development and improvement projects ensuring system and process performance and capabilities
Collaborate cross-divisionally to ensure system effectively enables regulatory business processes
Drive Demand Management for system, process, and data changes, and data clean-up
Manage a Portfolio of change initiatives within organization and alignment with the larger R&D Change Management Portfolio
Together with Business Digital Management, partner in the evaluation of performance metrics to determine where process changes, communication, and training may be needed to improve overall quality
Ensure processes are clearly documented, communicated, and understood
Support functional areas to ensure system training and documentation meet business needs
Ensure reporting tools meet the requirement to prepare and run reports for compliance monitoring, audit and inspections and audit remediation
Qualifications we seek in you
Minimum Qualifications/skills
Bachelor s degree with industry experience, preferable in a regulatory/ compliance area and experience with technical systems in a regulated environment.
Master s Degree and relevant industry experience preferable in a regulatory or labeling compliance area and experience with technical systems in a regulated environment
Broad range of knowledge of regulatory and labeling processes as well as overall knowledge of the end-to-end labeling processes, systems, and business requirements
Experience working closely with IT organizations in the design, development, and implementation of technical systems and tools
Knowledge of document management and/or structured content management as it applies to change control, content reuse, and labeling processes
Knowledge of system development lifecycle and data administration concepts
Demonstrated experience assessing and enabling process change.
Ability to lead and influence others outside of a direct reporting relationship
Broad organizational awareness and knowledge of touch points/interdependencies,
Demonstrated Change Management Knowledge
Process Management Knowledge (e.g., Six Sigma Green Belt)
Project Management Skills
Demonstrated capabilities managing and mentoring staff
Demonstrated collaborative skills and ability to work in cross-functional and international environments
Preferred Qualifications/skills
Advanced knowledge and capabilities applying technology within a business environment
Sigma Black Belt, Change Management Certification, PMI Certification.
Experience supporting and working with tools and systems used in the Regulatory Affairs environment
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
,Employement Category:
Employement Type: Full timeIndustry: IT - SoftwareRole Category: General / Other SoftwareFunctional Area: Not ApplicableRole/Responsibilies: Sr. Manager - Reg. AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai
Similar positions
Genpact India
Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in